Hillcrest Clinic Inc

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of proficiency testing records for Rh (D) testing and interview with Testing Person A, the laboratory did not rotate proficiency testing among all staff performing the Rh (D) testing. Findings: 1. All three proficiency testing events for Rh (D) testing performed in the year 2024 were performed by Testing Person A, even though there were other staff members who also performed Rh(D) testing on patient samples. 2. During interview on 1/27/25, Testing Person A confirmed that the proficiency testing was not rotated among other staff members for the entire year of 2024. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the patient testing log and proficiency testing (PT) records and interview with the testing person (TP), the laboratory failed to log the PT samples with the regular patient workload. Findings: 1. The laboratory utilized a "Patient Lab Log" to record the name of each patient tested for Rhesus (Rh) factor, the test results, and the results interpretation. 2. The PT records for eight events from 2019-2021 were reviewed. 3. For each PT event, the results were recorded on a separate worksheet titled "Quality Assurance Rh Testing UNKNOWN SAMPLES FROM PROFICIENCY TESTING." 4. Review of the PT testing dates in the "Patient Lab Log" determined that the PT samples were not logged into the "Patient Lab Log" with the regular patient workload. 5. During the survey on 09/29/2021 at 2:15 PM, the TP confirmed that the Rh factor PT samples were not logged into the "Patient Lab Log" with the regular patient workload. D5481 CONTROL PROCEDURES CFR(s): 493.1256(f)(g) (f) Results of control materials must meet the laboratory's and, as applicable, the manufacturer's test system criteria for acceptability before reporting patient test results. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- Based on review of the quality control (QC) records and interview with the testing person (TP), the laboratory failed to document the results of anti-D QC testing. Findings: 1. The laboratory listed all the reagent lot numbers, expiration dates, and QC results for Rhesus factor testing on the back of each "Patient Lab Log", which is documented on a tablet and printed daily. 2. The daily logs did not include the anti-D reagent and QC testing. 3. During the survey on 09/29/2021 at 2:05 PM, the TP confirmed that the anti-D QC was performed every time the bottle was opened, but it was not being recorded on the daily logs. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D5789 TEST RECORDS CFR(s): 493.1283(b) Records of patient testing including, if applicable, instrument printouts, must be retained. This STANDARD is not met as evidenced by: Based on record review and interview with laboratory staff, the lab did not keep intermediate Rh test results. Findings: 1. The laboratory documents the original patient Rh test results and the interpretation onto a handwritten log. The laboratory will then transcribe the log as a typed record; 2. The lab does not keep the original test log (intermediate handwritten test record), but discards this record and replaces it with the typed record; and 3. This was confirmed with laboratory staff on the day of survey. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --